biopsy-confirmed merkel cell carcinoma
Item
biopsy-confirmed merkel cell carcinoma with metastatic or loco-regional disease.
boolean
C0007129 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0007129 (UMLS CUI [2,1])
C1947913 (UMLS CUI [2,2])
Lesion must be palpable (superficial) and injectable
Item
patients must have at least one injectable lesion, defined as an easily palpable superficial lesion (cutaneous, subcutaneous or lymph nodal metastasis) that can be accurately localized, stabilized by palpation, and is superficial enough to enable it injection.
boolean
C0221198 (UMLS CUI [1,1])
C0746412 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C1272883 (UMLS CUI [2,2])
C0332149 (UMLS CUI [2,3])
ECOG Status
Item
ecog performance status score 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Age
Item
≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Life expectancy
Item
life expectancy of ≥ three months.
boolean
C0023671 (UMLS CUI [1])
neutrophil and platelet counts
Item
adequate neutrophil and platelet counts
boolean
C0948762 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
Renal and hepatic function
Item
adequate renal and hepatic function
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy
Item
willing to undergo pre-treatment lesion biopsy and post-treatment lesion biopsy
boolean
C0600109 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C2709094 (UMLS CUI [1,3])
C0600109 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C2709088 (UMLS CUI [2,3])
Contraception status
Item
use of effective contraception
boolean
C0420837 (UMLS CUI [1])
Informed consent
Item
signed informed consent document
boolean
C0021430 (UMLS CUI [1])
Gender and ethnicity
Item
members of all genders, races and ethnic groups are eligible for this trial
boolean
C0015031 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Prior chemotherapy or surgery or radiotherapy
Item
prior chemotherapy or a major surgical procedure within 3 weeks, or radiotherapy within 2 weeks prior to first study treatment
boolean
C1514457 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
No concurrent anti-cancer treatment or investigational drugs
Item
no concurrent anti-cancer treatment (including topical agents such as imiquimod) or investigational agents
boolean
C0920425 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Untreated brain metastases
Item
active, untreated brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Pregnant or nursing
Item
pregnant or nursing
boolean
C0549206 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
use of systemic immunosuppressive agents
Item
use of any systemic immunosuppressive agents
boolean
C0021079 (UMLS CUI [1])
Immunosuppression
Item
immunosuppressed patients
boolean
C4048329 (UMLS CUI [1])
Psychiatric comorbidity
Item
uncontrolled depression or other major psychiatric disorder
boolean
C0004936 (UMLS CUI [1])